N/A
N=165
Acute Neurobehavioral Program for Improving Functional Status After TBI
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT01166386 ↗Enrolled (actual)
165
Serious AEs
0.6%
Results posted
Oct 2021
Primary outcome: Primary: Functional Independence Measure Scores — 88.11; 89.79; 120.57; 119.67 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FANCI (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Independence Measure Scores |
88.11; 89.79; 120.57; 119.67; 48.98; 50.93 | — |
| SECONDARY Neurobehavioral Rating Scale |
56.23; 58.70; 48.4857; 50.2985; 48.9778; 50.9318 | — |
Summary
The specific aims of the proposed study are to 1) evaluate the efficacy of FANCI for improving functional status following treatment using the FIM, 2) examine the impact of FANCI on broader outcome measures of general emotional and behavioral functioning and productive activity in the community as measured post-treatment and at 6-month follow-up, 3) examine contributions of participant injury severity and cognitive status at time of treatment to treatment outcome and treatment response, 4) examine contributions of treatment variables of session topic and mastery, caregiver presence, and concurrent therapies on treatment outcome and treatment response for inpatients with TBI. Primary outcome measure is the (FIM). We will secondarily compare scores on the Disability Rating Scale (DRS), Glasgow Outcome Scale-Extended (GOSE), Rehabilitation Intensity of Therapy Scale (RITS), and Frontal Systems Behavior Scale (FRsBe). Our design is a parallel groups, single-blind, randomized, controlled trial. We will enroll 150 (75 treatment, 75 control) participants. Inclusion Criteria: Mod to Sev TBI based on time to commands, English speaker, Length of stay ≥ 5 days in acute BI rehabilitation Unit, 18 years of age or older, ≥ 79 on GOAT.
Eligibility Criteria
Inclusion Criteria: at least 18 years old, English speaking, traumatic brain injury inpatient, out of post traumatic amnesia, not psychotic -
Exclusion Criteria: Prisoner, psychotic, not medically stable
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Data sourced from ClinicalTrials.gov (NCT01166386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.